Sandoz Inc., et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applications; Correction
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Abstract
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on June 21, 2024. The document announced the withdrawal of approval of 20 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of July 22, 2024. The document indicated that FDA was withdrawing approval of the ANDA 076648 for nitrofurantoin (monohydrate/macrocrystals) capsules, 75 milligrams (mg) and 25 mg, held by Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Rd., East Windsor, NJ 08520; and the ANDA 090723 for duloxetine hydrochloride capsules, delayed-release pellets, Equivalent to (EQ) 20 mg base, EQ 30 mg base, and EQ 60 mg base, held by Marksans Pharma, Inc., U.S. Agent for Marksans Pharma Ltd., 150 Motor Pkwy., Suite 401, 4th Floor, Rm. 430, Hauppauge, NY 11788. Before FDA withdrew the approval of these ANDAs, Aurobindo Pharma USA Inc., and Marksans Pharma, Inc., U.S. Agent for Marksans Pharma Ltd., informed FDA that they did not want the approval of the ANDAs withdrawn. Because Aurobindo Pharma USA Inc. and Marksans Pharma, Inc., U.S. Agent for Marksans Pharma Ltd., timely requested that approval of their respective ANDAs not be withdrawn, the approvals are still in effect. This notice corrects these errors.
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<title>Federal Register, Volume 89 Issue 178 (Friday, September 13, 2024)</title>
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[Federal Register Volume 89, Number 178 (Friday, September 13, 2024)]
[Notices]
[Pages 74968-74969]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-20873]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2803]
Sandoz Inc., et al.; Withdrawal of Approval of 20 Abbreviated New
Drug Applications; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register on June 21, 2024. The document
announced the withdrawal of approval of 20 abbreviated new drug
applications (ANDAs) from multiple applicants, withdrawn as of July 22,
2024. The document indicated that FDA was withdrawing approval of the
ANDA 076648 for nitrofurantoin (monohydrate/macrocrystals) capsules, 75
milligrams (mg) and 25 mg, held by Aurobindo Pharma USA Inc., 279
Princeton-Hightstown Rd., East Windsor, NJ 08520; and the ANDA 090723
for duloxetine hydrochloride capsules, delayed-release pellets,
Equivalent to (EQ) 20 mg base, EQ 30 mg base, and EQ 60 mg base, held
by Marksans Pharma, Inc., U.S. Agent for Marksans Pharma Ltd., 150
Motor Pkwy., Suite 401, 4th Floor, Rm. 430, Hauppauge, NY 11788. Before
FDA withdrew the approval of these ANDAs, Aurobindo Pharma USA Inc.,
and Marksans Pharma, Inc., U.S. Agent for Marksans Pharma Ltd.,
informed FDA that they did not want the approval of the ANDAs
withdrawn. Because Aurobindo Pharma USA Inc. and Marksans Pharma, Inc.,
U.S. Agent for Marksans Pharma Ltd., timely requested that approval of
their respective ANDAs not be withdrawn, the approvals are still in
effect. This notice corrects these errors.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 301-
796-3471, <a href="/cdn-cgi/l/email-protection#fdb09c8f89959cd3b39a88849893bd9b999cd395958ed39a928b"><span class="__cf_email__" data-cfemail="7a371b080e121b54341d0f031f143a1c1e1b54121209541d150c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, June 21,
2024 (89 FR 52057), appearing on page
[[Page 74969]]
52058 in FR Doc. 2024-13660, the following correction is made:
On page 52058, in the table, the entries for ANDA 076648 and ANDA
090723 are removed.
Dated: September 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-20873 Filed 9-12-24; 8:45 am]
BILLING CODE 4164-01-P
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